Heart Failure and Edema Costs in Patiromer and SZC Users.

BACKGROUND: Previous work suggested differences between patients taking patiromer or sodium zirconium cyclosilicate (SZC) in real-world risk of heart failure (HF) hospitalizations and edema hospitalizations or emergency department (ED) visits (edema events). We further investigated these differences to assess economic importance. Retrospective study using published event rates and mean costs derived from Optum's de-identified Clinformatics® Data Mart (CDM) Database. METHODS: We designed a model to estimate adjusted economic offsets that combined respective patiromer and SZC HF hospitalization (25.1 and 35.8; difference 10.7 [95% confidence interval [CI]2: 2.6-18.8]) and edema event (3.4 and 7.1; difference 3.6 [95% CI: 1.7-7.1]) rates/100 person-years from the original published work with costs from our parallel data extract spanning 2019-2021, adjusted to 2021 US dollars. RESULTS: In a base case of mean HF hospitalization, edema event, and 30-count potassium-binder prescription costs from our data extract, the estimated mean savings with patiromer was $1,428 per person per year (PPPY; 95% CI: -$1,508 to $4,652). Respective costs PPPY for patiromer vs SZC were $8,526 vs $12,622 (difference $4,096 [95% CI: $1,160-$7,320]) for HF hospitalization and edema events, and $10,649 vs $7,981 (difference -$2,668) for potassium binders, totaling $19,175 for patiromer vs $20,603 for SZC. CONCLUSION: With differing drug costs, hospitalization and ED costs offset this difference when event rates were numerically small. Model outcomes were driven by HF hospitalization cost and least influenced by edema ED visit cost. A limitation was that the CDM data extract may differ from the original work.

Evaluation of longer- vs short-term use of patiromer on health care resource utilization in the patiromer longer-term use evaluation (VALUE) study.

BACKGROUND: Studies suggest that continuous long-term use of patiromer by patients with hyperkalemia is associated with less health care resource utilization compared with not using potassium binders. OBJECTIVE: To retrospectively evaluate health care resource utilization and costs with longer-term adherent vs short-term use of patiromer. METHODS: Time-restricted extracts from Optum's de-identified Clinformatics® Data Mart Database (CDM; January 2016-May 2019) and Symphony Health (SHA; January 2016-September 2018) deidentified databases were analyzed. Both include participants enrolled in commercial and privatized public insurance programs (SHA includes some government programs). Both integrate health care claims data from medical and pharmacy claims. Patients aged 18 years or older with hyperkalemia and an index patiromer prescription were selected. Patiromer use was identified as short-term (<2 months) and any fill quantity or adherent longer-term with claims for at least 2 consecutive months and fill quantities of at least 80% of the total days. Groups were matched on multiple categorical covariates to control for demographic variables, baseline characteristics, and markers of disease severity. Random sampling without replacement was performed 50 times to identify 50 sets of patients matched from the short-term cohort to the longer-term cohort. Health care costs/charges and encounters were compared for a 6-month post-index period using t-tests. RESULTS: Of the CDM patients, 1,267 (40.2%) vs 1,887 (59.8%) and of the SHA patients, 2,234 (35.1%) vs 4,132 (64.9%) experienced longer-term vs short-term patiromer use, respectively. Patient sampling selected 242 and 485 patient-matched pairs from CDM and SHA databases, respectively. At 6 months post-index in longer-term vs short-term patiromer groups (P < 0.0001 for all differences shown), respective mean medical and prescription costs/charges were $42,000 vs $54,311 (-$12,311) and $6,816 vs $4,786 (+$2,030), respectively, for CDM patients and $75,147 vs $84,414 (-$9,267) and $4,689 vs $3,736 (+$953) for SHA patients. In the CDM database, medical costs were lower for longer-term vs short-term cohorts for end-stage renal disease services charges ($10,342 vs $14,976 [-$4,634]), inpatient charges ($15,789 vs $21,473 [-$5,684]), and office visit charges ($10,152 vs $13,152 [-$3,000]). Patient out-of-pocket costs ($658 vs $420 [+$238]) and total prescription charges ($6,158 vs $4,366 [+$1,792]) were higher for the longer-term cohort of CDM patients, with similar findings in the SHA dataset. CONCLUSIONS: Adherent, longer-term use of patiromer is associated with significantly lower medical costs offsetting higher prescription costs, driven by the largest changes in inpatient and clinic services at CDM and SHA, respectively. This illustrates an economic value of longer-term adherence to patiromer.

Social determinants of patiromer adherence and abandonment: An observational, retrospective, real-world claims analysis.

BACKGROUND: Hyperkalemia is a frequent and serious complication in chronic kidney disease (CKD) that can impede continuation of beneficial evidence-based therapies. Recently, novel therapies such as patiromer have been developed to treat chronic hyperkalemia, but their optimal utility hinges on adherence. Social determinants of health (SDOH) are critically important and can impact both medical conditions and treatment prescription adherence. This analysis examines SDOH and their influence on adherence to patiromer or abandonment of prescriptions for hyperkalemia treatment. METHODS: This was an observational, retrospective, real-world claims analysis of adults with patiromer prescriptions and 6- and 12-months pre- and post-index prescription data in Symphony Health's Dataverse during 2015-2020, and SDOH from census data. Subgroups included patients with heart failure (HF), hyperkalemia-confounding prescriptions, and any CKD stages. Adherence was defined as >80% of proportion of days covered (PDC) for ≥60 days and ≥6 months, and abandonment as a portion of reversed claims. Quasi-Poisson regression modeled the impact of independent variables on PDC. Abandonment models used logistic regression, controlling for similar factors and initial days' supply. Statistical significance was p<0.05. RESULTS: 48% of patients at 60 days and 25% at 6 months had a patiromer PDC >80%. Higher PDC was associated with older age, males, Medicare/Medicaid coverage, nephrologist prescribed, and those receiving renin-angiotensin-aldosterone system inhibitors. Lower PDC correlated with higher out-of-pocket cost, unemployment, poverty, disability, and any CKD stage with comorbid HF. PDC was better in regions with higher education and income. CONCLUSIONS: SDOH (unemployment, poverty, education, income) and health indicators (disability, comorbid CKD, HF) were associated with low PDC. Prescription abandonment was higher in patients with prescribed higher dose, higher out-of-pocket costs, those with disability, or designated White. Key demographic, social, and other factors play a role in drug adherence when treating life-threatening abnormalities such as hyperkalemia and may influence patient outcomes.

Real-world clinical burden and economic assessment associated with hyperkalaemia in a large integrated healthcare system: a retrospective analysis.

BACKGROUND: Hyperkalaemia (HK) is a serious and potentially life-threatening condition. Both acute and chronic conditions may alter potassium homeostasis. Our aim is to describe HK incidence, clinical outcomes, and associated resource use within a large, integrated healthcare system. METHODS: Adult patients seen at Intermountain Healthcare facilities with a serum potassium (sK) result between January 1, 2003 and December 31, 2018 were retrospectively studied. Descriptive assessment of a population with detected HK, defined by any sK > 5.0 mmol/L and HK frequency and severity to associated resource use and characteristics of HK predictors were made. Multivariable Cox hazard regression was used to evaluate HK to outcomes. RESULTS: Of 1,208,815 patients included, 13% had HK. Compared to no-HK, HK patients were older (60 ± 18 vs 43 ± 18 years, P < 0.001), male (51% vs 41%, P < 0.001), and had greater disease burden (Charlson Comorbidity Index 3.5 ± 2.8 vs 1.7 ± 1.4, P < 0.001). At 3 years, more HK patients experienced major adverse cardiovascular events (MACEs) (19 vs 3%, P < 0.001), persisting post-adjustment (multivariable hazard ratio = 1.60, P < 0.001). They incurred higher costs for emergency department services ($552 ± 7,574 vs $207 ± 1,930, P < 0.001) and inpatient stays ($10,956 ± 93,026 vs $1,477 ± 21,423, P < 0.001). HyperK Risk Scores for the derivation and validation cohorts were: 44% low-risk, 45% moderate-risk, 11% high-risk. Strongest HK predictors were renal failure, dialysis, aldosterone blockers, diabetes, and smoking. CONCLUSION: Within this large system, HK was associated with a large clinical burden, affecting over 1 in 10 patients; HK was also associated with increased 3-year MACE risk and higher medical costs. Although risk worsened with more severe or persistently recurring HK, even mild or intermittent HK episodes were associated with significantly greater adverse clinical outcomes and medical costs. The HyperK Score predicted patients who may benefit from closer management to reduce HK risk and associated costs. It should be remembered that our assumptions are valid only for detected HK and not HK per se.

The clinical and economic impact of cytomegalovirus infection in recipients of hematopoietic stem cell transplantation.

BACKGROUND: CMV infection (CMV-I) remains an important complication of hematopoietic stem cell transplantation (HSCT). METHODS: This was a retrospective, single-center cohort study in HSCT recipients. Primary outcomes were adjusted cost and all-cause mortality. Secondary analyses investigated CMV risk factors and the effect of serostatus. RESULTS: Overall, 690 transplant episodes were included (allogeneic [n = 310]; autologous [n = 380]). All received preemptive CMV antiviral therapy at first detectable DNAemia. CMV-I occurred in 34.8% of allogeneic and 2.1% of autologous transplants; median time to onset was 45 days. In allogeneic HSCT recipients, the primary risk factor for CMV-I was CMV donor/recipient (D/R) serostatus. In a Markov multi-state model for allogeneic HSCT recipients, the hazard ratio for CMV-I and relapse was 1.5 (95% CI 0.8-2.8) and for CMV-I and mortality 2.4 (95% CI 0.9-6.5). In a multivariable model for all patients, CMV-I was associated with increased total cost (coefficient = 0.21, estimated incremental daily cost USD $500; P = 0.02). Cost was attenuated in allogeneic HSCT recipients (coefficient = 0.13, USD $699 vs $613, or $24 892 per transplant episode; P = 0.23). CMV disease (CMV-D) complicated 29.6% of CMV-I events in allogeneic HSCT recipients, but was not associated with an incrementally increased adjusted risk of mortality compared with CMV-I alone. CMV-I (56.4%) and CMV-D (19.8%) were significantly overrepresented in D-/R+ serostatus HSCT recipients, and mortality was higher in R+ HSCT recipients. CONCLUSIONS: Despite early preemptive antiviral treatment, CMV-I impacts clinical outcomes and cost after HSCT, but the impact on cost is less pronounced in allogeneic HSCT recipients compared with autologous HSCT recipients.